NCT02795208

Brief Summary

This study test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 5, 2016

Last Update Submit

June 12, 2016

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

  • Right ventricle assessment by transesophageal echocardiography

    intraoperative

Secondary Outcomes (2)

  • Atelectasis assessment by transesophageal echocardiography

    intraoperative

  • PaO2 and respiratory compliance

    intraoperative

Study Arms (2)

Control group

NO INTERVENTION

Patients received standard protective ventilation along the protocol.

Recruitment maneuver group

EXPERIMENTAL

Patient received a lung recruitment maneuver after cardiopulmonary bypass. The recruitment maneuver consists in 10 breaths at 40/20 cmH2O of plateau pressure and PEEP, respectively. Then, the .ventilatory settings back to protective ventilation but adding 10 cmH2O of PEEP to keep the lungs open.

Procedure: Lung recruitment maneuver

Interventions

Lung recruitment maneuverPROCEDURE

The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (20 cmH2O of PEEP + 20 cmH2O of driving pressure) for 10 breaths.

Recruitment maneuver group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cardiovascular surgery with cardiopulmonary bypass.
  • Patients with a New York Heart Association (NYHA) class I-II,
  • Pre-operative left ventricular ejection fraction ≥ 50 %.
  • Euroscore ≤ 6.

You may not qualify if:

  • TEE contraindications.
  • Hemodynamically unstable
  • Needi for inotropic support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Silvina Longo, MD

    Hospital Privado de Córdoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 5, 2016

First Posted

June 10, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06